Cancer combo trial pulled before it even started
NCT ID NCT04031872
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study aimed to test a combination of two drugs—LY3200882 and capecitabine—in people with advanced colorectal cancer that had stopped responding to chemotherapy. The goal was to see if the combination could re-sensitize tumors to treatment. However, the trial was withdrawn before enrolling any patients, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY3200882 (a TGF-beta inhibitor) combined with capecitabine (a chemotherapy drug)
- What this could lead to
- If it had worked, this could have pointed toward a new treatment option for people with chemotherapy-resistant colorectal cancer.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. It is unclear if the combination would have been safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Started
-
Jan 2020
- Finished
-
Jan 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histological or cytological proof of CRC; 2. Disease progression or relapse upon at least one line of treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed); 3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia; 4. Age ≥ 18 years; 5. Able and willing to give written informed consent; 6. WHO performance status of ≤ 1; 7. LVEF ≥ 55%; 8. Able and willing to undergo blood sampling for PK and PD analysis; 9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment 10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity; 11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part); 12. Minimal acceptable safety laboratory values 1. ANC of ≥ 1.5 x 109 /L 2. Platelet count of ≥ 100 x 109 /L 3. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases 4. Renal function as defined by serum creatinine ≤1.5 x ULN 5. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD); 13. Negative pregnancy test (urine or serum) for female patients with childbearing potential. Exclusion Criteria: 1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment; 2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD\*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A\>T genotype); 3. Symptomatic or untreated leptomeningeal disease; 4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (\<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids; 5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart. 6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LY3200882 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection); 7. Woman who are pregnant or breast feeding; 8. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed; 9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery; 10. Active infection requiring systemic antibiotics or uncontrolled infectious disease; 11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients; 12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study; 13. Known hypersensitivity to one of the study drugs or excipients. 14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year (when used consistently and correctly) during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine. More information is available in section 5.2.4. 15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in section 5.2.4.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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